To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Condition	Treatment or Intervention	Phase
Mycobacterium avium-intracellulare Infection HIV Infections	Drug: Ethambutol hydrochloride  Drug: Clarithromycin  Drug: Rifabutin	Phase III

Further Study Details: 

Expected Total Enrollment:  450

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Isoniazid for TB prophylaxis ONLY. Patients must have:
• HIV infection.
• MAC infection.
• Life expectancy of at least 16 weeks.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Perceived unreliability or unavailability for frequent monitoring. Concurrent Medication: Excluded:
• Antimycobacterial drugs other than the study drugs.
• Carbamazepine.
• Terfenadine.
• Theophylline. Patients with the following prior condition are excluded: History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol. Prior Medication: Excluded within 7 days prior to study entry:
• Rifabutin.
• Rifampin.
• Ethionamide.
• Cycloserine.
• Clofazimine.
• Ethambutol.
• Amikacin.
• Ciprofloxacin.
• Ofloxacin.
• Sparfloxacin.
• Azithromycin.
• Clarithromycin.
• Pyrazinamide. Excluded within 14 days prior to study entry:
• Carbamazepine.
• Terfenadine.
• Theophylline.

Arizona
      McDowell Clinic, Phoenix,  Arizona,  85006,  United States
      Maricopa Med Research Foundation, Phoenix,  Arizona,  85008,  United States
California
      San Francisco Veterans Administration Med Ctr, San Francisco,  California,  94121,  United States
      Ctr for Special Immunology, Irvine,  California,  92718,  United States
      HIV Research Group, San Diego,  California,  92102,  United States
      Highland Gen Hosp / San Francisco Gen Hosp, Oakland,  California,  946021018,  United States
      Combat Group, Los Angeles,  California,  90028,  United States
      Bay Harbor Hosp, Harbor City,  California,  90710,  United States
      Saint Francis Mem Hosp, San Francisco,  California,  94109,  United States
      Sunnyvale Med Clinic, Sunnyvale,  California,  94086,  United States
      UCSD / Ctr for Special Immunology, San Diego,  California,  92103,  United States
      Cedars Sinai Med Ctr, Los Angeles,  California,  90048,  United States
District of Columbia
      Veterans Administration Med Ctr, Washington,  District of Columbia,  20422,  United States
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
Florida
      TheraFirst Med Ctrs Inc, Fort Lauderdale,  Florida,  33308,  United States
      Dr Nelson Zide, Hollywood,  Florida,  33021,  United States
      Bay Area AIDS Consortium, Tampa,  Florida,  33609,  United States
      Infectious Disease Consultants, Altamonte Springs,  Florida,  32701,  United States
      Ctr for Special Immunology, Miami Beach,  Florida,  33140,  United States
      Gary Richmond MD, Fort Lauderdale,  Florida,  33316,  United States
      Dr Barry Rodwick, Safety Harbor,  Florida,  34695,  United States
      Dr Frank Tornaka, Fort Lauderdale,  Florida,  33316,  United States
Georgia
      Infectious Disease Research Consortium of Georgia, Atlanta,  Georgia,  30345,  United States
Illinois
      Dr Daniel Berger, Chicago,  Illinois,  60657,  United States
Kansas
      Univ of Kansas School of Medicine, Wichita,  Kansas,  67214,  United States
Louisiana
      Tulane Univ Med School, New Orleans,  Louisiana,  701122699,  United States
Michigan
      Dr Arnold Markowitz, Keego Harbor,  Michigan,  48320,  United States
Nebraska
      Univ of Nebraska Med Ctr / HIV Clinic, Omaha,  Nebraska,  681985130,  United States
New Jersey
      East Orange Veterans Administration Med Ctr, East Orange,  New Jersey,  07018,  United States
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
New York
      Long Island Jewish Med Ctr, New Hyde Park,  New York,  11042,  United States
      Chelsea Village Med Ctr / Saint Vincent's Hosp, New York,  New York,  10014,  United States
      Community Health Network, Rochester,  New York,  14620,  United States
North Carolina
      Nalle Clinic, Charlotte,  North Carolina,  28207,  United States
Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
      Polyclinic Med Ctr, Harrisburg,  Pennsylvania,  17110,  United States
South Carolina
      Dr Alfred F Burnside Jr, Columbia,  South Carolina,  29204,  United States
      Charleston Veterans Administration Med Ctr, Charleston,  South Carolina,  294015799,  United States
Texas
      Univ TX San Antonio Health Science Ctr, San Antonio,  Texas,  78284,  United States
      Houston Veterans Administration Med Ctr, Houston,  Texas,  77030,  United States
      Central Texas Med Foundation, Austin,  Texas,  78751,  United States
Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22203,  United States
Wisconsin
      Univ of Wisconsin School of Medicine, Madison,  Wisconsin,  53792,  United States
      Milwaukee County Med Complex, Milwaukee,  Wisconsin,  53226,  United States

Study ID Numbers:  048D; CS 087250-999
Record last reviewed:  June 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002101
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08